Sealing systems for a reservoir of an on-body injector

ABSTRACT

An on-body injector includes a drug reservoir having an outlet. First and second pistons may be positioned within the reservoir, with the second piston first being moved to open the outlet, followed by the first piston being moved to convey a drug from the reservoir via the outlet. The reservoir may instead include a cover, with a valve positioned between the outlet and the cover. The valve is rotated to place a channel of the valve in fluid communication with a through-hole of the cover, allowing flow from the reservoir via the outlet. The reservoir may instead include a valve movable from a condition in which it deforms the outlet, preventing flow through the outlet, to a condition allowing flow. The reservoir may instead include a seal that is deformed by an increase in pressure within the reservoir, with the deformed seal being open to allow flow through the outlet.

BACKGROUND Field of the Disclosure

The present disclosure relates to drug delivery devices. Moreparticularly, the present disclosure relates to devices mounted to thebody for automatically delivering a drug to a patient.

Description of Related Art

Delivery of liquid drugs to a patient via injection using a needle orsyringe is well-known. More recently, devices that automate the deliveryof liquid drugs have been introduced. These devices (which are commonlyreferred to as “on-body devices” or “on-body injectors”) are mounted orotherwise secured to the body of the patient (e.g., to the arm orabdomen) and remain in place for an extended amount of time (on theorder of hours or days), injecting an amount of the drug into the bodyof the patient at one or more scheduled times. For example, a device maybe configured to deliver a drug over the span of 45 minutes, withdelivery beginning 27 hours after the device has been activated andapplied to a patient (to ensure that the drug is not delivered soonerthan 24 hours after a medical procedure or treatment). These devicesimprove upon manual methods by obviating the need for the patient toinject themselves with the drug (which carries heightened risks of thepatient improperly administering the injection or injecting the drug atan inappropriate time) or to return to a medical facility for one ormore injections by a technician or medical professional.

One known on-body device 10 is shown in FIGS. 1 and 2. The device 10 ofFIG. 1 includes a housing 12 that contains or encloses the functionalcomponents of the device 10, which are shown in FIGS. 3 and 4.

The internal components of the device 10 include a reservoir 14 that isconfigured to be filled with a liquid drug to be delivered to thepatient. An upper surface of the housing 12 includes a fill indicator 16that provides a visual indication of the amount of fluid in thereservoir 14. In addition to the fill indicator 16, the upper surface ofthe housing 12 may include printed information, such as informationregarding the drug to be delivered. The upper surface of the housing 12may be formed of a translucent material, which allows light from astatus light 18 (which may be configured as a light-emitting diode)mounted within the housing 12 (FIG. 1) to be seen through the uppersurface of the housing 12. The status light 18 is electrically coupledto a controller or processor (which may be a CPU or MPU configured as acomputer chip mounted to a printed circuit board positioned within thehousing 12, for example) that carries software for executing a drugdelivery routine. The status light 18 receives signals from thecontroller and emits light to provide information regarding a status ofthe device 10. This may include emitting differently colored lightand/or emitting light in different flashing patterns to indicatedifferent conditions, such as a blinking orange light to indicate thatthe device 10 is ready to be applied to a patient, a blinking greenlight to indicate proper operation of the device 10, and a blinking redlight to indicate an error or other condition. One or more batteries 20provides power to the status light 18 and the other electricalcomponents of the device 10.

The drug is injected into the reservoir 14 using a (typicallypre-filled) syringe 22 via a port 24 incorporated into the bottom orunderside of the housing 12 (FIG. 4) and fluidically connected to thereservoir 14. FIGS. 1 and 2 illustrate an applicator 26 that isremovably associated with the underside of the housing 12 and used incombination with the syringe 22 to fill the reservoir 14 via the port24. The drug is most typically injected into the reservoir 14 by amedical professional immediately before the device 10 is secured to thepatient to ensure that the proper drug is supplied, along with theproper amount.

A piston or plunger 28 (FIG. 4) positioned within the reservoir 14 ismoved (from left to right, in the orientation of FIG. 4) as the spacewithin the reservoir 14 is filled by the inflowing drug. Movement of thepiston 28 into its final position (when the reservoir 14 has been filledwith the appropriate amount of the drug) causes a portion of a rodassociated with the piston 28 to extend from the reservoir 14 to createan electrical connection, which activates the device 10. Activation ofthe device 10 may include a signal, such as a buzzer providing anaudible indication that the device 10 has been activated and/or a lightemitted by the status light 18.

When the device 10 has been activated, it is mounted or secured to thebody of the patient. The applicator 26 is first removed from theunderside of the housing 12 and discarded, followed by a pull tab 30being manipulated to remove a release film from an adhesive pad 32associated with the underside of the housing 12. The housing 12 is thenpressed against the body of the patient, with the adhesive pad 32 facingthe body. An adhesive present on the adhesive pad 32 causes the adhesivepad 32 (and, hence, the housing 12) to adhere to the body.

Some predetermined time after the device 10 has been activated (whichmay be on the order of three to five minutes, for example), a distal endportion of a cannula 34 is introduced into the skin of the patient via acannula window 36 defined in the housing 12 (FIGS. 3 and 4). The cannula34 (which remains partially positioned within the skin of the patientfor as long as the device 10 is in use) is formed of a flexible orsemi-rigid material, such as a plastic material, for improved patientcomfort.

As the cannula 34 is not itself configured to pierce the skin, anassociated needle 38 is provided within the lumen of the cannula 34,with a sharp or beveled distal end of the needle 38 extending out of adistal end of the cannula 34. A midsection of the needle 38 is mountedwithin a needle carriage 40, while a proximal end 42 of the cannula 34is mounted within a cannula carriage 44 that is initially positioneddirectly adjacent to the needle carriage 40. The needle carriage 40 ispivotally connected to an end of a linkage or crank arm 46, with anopposite end of the linkage 46 being associated with a torsion spring48. At the designated time (e.g., 3-5 minutes after the device 10 hasbeen activated), the controller causes a lever (not visible) to bereleased, which allows the spring 48 to recoil, in turn rotating thelinkage 46, which rotation causes the needle carriage 40 to move along alinear track 50 from a first position adjacent to the spring 48 (FIG. 3)to a second position spaced away from the spring 48. Movement of theneedle carriage 40 causes corresponding movement of the cannula carriage44 along the track 50, with the cannula 34 and the distal portion of theneedle 38 moving together in a direction away from the spring 48. Movingthe carriages 40 and 44 into the second position causes the sharp distalend of the needle 38 to advance out of the housing 12 via the cannulawindow 36 and pierce the skin. The cannula 34 is carried by or movesalong with the distal portion of the needle 38, such that the needle 38piercing the skin will also cause the distal end of the cannula 34 toenter into the skin.

Continued recoiling of the spring 48 causes further rotation of thelinkage 46, which has the effect of moving the needle carriage 40 backtoward the spring 48 (i.e., back toward its first position). Rather thanmoving along with the needle carriage 40, the cannula carriage 44 isheld in its second position (FIG. 3) by a lock or latch 52. As themovement of the needle carriage 40 is not restricted by the lock orlatch 52, the needle carriage 40 will return to its first position,while the cannula carriage 44 remains in its second position (with thefinal positions of both carriages 40 and 44 shown in FIG. 3).

Movement of the needle carriage 40 in a proximal direction away from thecannula carriage 44 causes the needle 38 to partially (but not fully)retract from the cannula 34. In the final condition shown in FIG. 3, thedistal end of the needle 38 is positioned within the cannula 34 (e.g.,adjacent to a midsection or midpoint of the cannula 34), while thedistal end of the cannula 34 remains positioned within the skin. Aproximal end of the needle 38 extends into fluid communication with thereservoir 14, such that the needle 38 provides a fluid path from thereservoir 14 to the cannula 34 when the carriages 40 and 44 are in thefinal condition illustrated in FIG. 3. Due to the distal end of thecannula 34 remaining positioned within the skin, subsequent advancementof the drug out of the reservoir 14 (e.g., 27 hours after the device 10has been activated) will cause the drug to move into the needle 38 (viathe proximal end of the needle 38), through the needle 38 (to its distalend), and into the cannula 34. The drug is then delivered to the patient(e.g., over the course of a 45-minute session) via the distal end of thecannula 34 positioned within the skin.

As for the mechanism by which the drug is advanced out of the reservoir14, the device 10 includes a lever 54 mounted to a pivot point 56 (FIG.4). The lever 54 includes a first arm 58 configured and oriented tointeract with a first gear 60 and a second arm 62 configured andoriented to interact with a second gear 64. A tab 66 extends from anopposite end of the lever 54 and is configured and oriented toalternately move into and out of contact with two electrical contacts 68and 70 (electrically coupled to a printed circuit board, which is notshown) as the lever 54 pivots about the pivot point 56.

A first wire or filament 72 extends from the lever 54, around a firstpulley 74, and into association with a first electrical contact 76. Asecond wire or filament 78 extends from the lever 54 in the oppositedirection of the first wire 72, around a second pulley 80, and intoassociation with a second electrical contact 82. The wires 72 and 78(which are commonly referred to as “muscle wires”) are formed of a shapememory alloy (e.g., Nitinol), which causes them to heat up and contractwhen a current flows through them, while being allowed to stretch whenthe current is removed and the wire 72, 78 cools. Current is alternatelyapplied to the two wires 72 and 78, causing the one carrying a currentto heat up and contract while the other one is allowed to stretch. Thewire 72, 78 that contacts will pull on the lever 54, causing it to pivotabout the pivot point 56. Thus, alternately applying current to the twowires 72 and 78 will cause the wires 72 and 78 to alternately contactand stretch, which in turn causes the lever 54 to pivot back and forthabout the pivot point 56.

At the designated time (e.g., 27 hours after the device 10 has beenactivated), the controller provides commands that cause current to bealternately applied to the muscle wires 72 and 78, which causes thelever 54 to alternately pivot about the pivot point 56 in opposite firstand second directions. Pivotal movement of the lever 54 in the firstdirection will cause the first arm 58 of the lever 54 to engage androtate the first gear 60 an incremental amount, while pivotal movementof the lever 54 in the second direction will cause the second arm 62 ofthe lever 54 to engage and rotate the second gear 64 an incrementalamount (in the same direction in which the first gear 60 is rotated bythe first arm 58). Both gears 60 and 64 are associated with a commonshaft 84 (which is shown in FIG. 3 and may be formed with the gears 60and 64 as a single, molded piece), such that rotation of either gear 60,64 will cause the shaft 84 to rotate about its central axis. The shaft84 is mechanically coupled to the piston 28 within the reservoir 14,with rotation of the shaft 84 causing the piston 28 to move toward itsinitial position (e.g., by a threaded connection whereby rotation of theshaft 84 is translated into movement of the piston 28 along the lengthof the reservoir 14). As the piston 28 moves toward its initial position(from right to left in the orientation of FIG. 4), it will force thedrug out of the reservoir 14 via the proximal end of the needle 38. Asdescribed above, the drug will flow through the needle 38, into andthrough the cannula 34, and into the body of the patient.

After the drug has been delivered (e.g., over the course of a 45-minutesession), the controller alerts the patient via a visual cue from thestatus light 18 and/or an audible cue from the buzzer that drug deliveryis complete. Subsequently, the patient removes the device 10 from theirskin and discards the device 10.

While devices of the type described above have proven adequate, there isroom for improvement of them. For example, the reservoir may be providedwith differently configured sealing systems, with differentconfigurations providing different advantages compared to theconfiguration of the sealing system of a conventional device.

SUMMARY

There are several aspects of the present subject matter which may beembodied separately or together in the devices and systems described andclaimed below. These aspects may be employed alone or in combinationwith other aspects of the subject matter described herein, and thedescription of these aspects together is not intended to preclude theuse of these aspects separately or the claiming of such aspectsseparately or in different combinations as set forth in the claimsappended hereto.

In one aspect, an on-body injector includes a housing, an adhesive padassociated with a lower surface of the housing and configured to beremovably attached to a human body surface, and a drug reservoirpositioned within the housing and including an outlet. First and secondpistons are positioned within the drug reservoir. The on-body injectorfurther includes a needle fluidically connected to the outlet of thedrug reservoir and a controller configured to control the components ofthe on-body injector to execute a drug delivery routine. The secondpiston is configured to be moved from a first position in which itprevents fluid flow from the drug reservoir via the outlet to a secondposition in which it allows fluid flow from the drug reservoir via theoutlet. The first piston is configured to be moved with respect to thesecond piston in the second position to convey a drug out of the drugreservoir via the outlet during a drug delivery routine.

In another aspect, an on-body injector includes a housing, an adhesivepad associated with a lower surface of the housing and configured to beremovably attached to a human body surface, and a drug reservoirpositioned within the housing and including an outlet. A cover defininga through-hole is associated with the reservoir, with a valve at leastpartially positioned between the outlet of the drug reservoir and thecover. The on-body injector also includes a needle is fluidicallyconnected to the outlet of the drug reservoir and a controllerconfigured to control the components of the on-body injector to executea drug delivery routine. The valve defines a channel and is configuredto be rotated from a first position in which the channel is not orientedto allow fluid flow from the through-hole to the outlet to a secondposition in which the channel is oriented to allow fluid flow from thethrough-hole to the outlet.

In yet another aspect, an on-body injector includes a housing, anadhesive pad associated with a lower surface of the housing andconfigured to be removably attached to a human body surface, and a drugreservoir positioned within the housing and including a deformableoutlet having an associated valve. A needle is fluidically connected tothe outlet of the drug reservoir, while a controller is configured tocontrol the components of the on-body injector to execute a drugdelivery routine. The valve is configured to be moved from a firstcondition in which it engages and deforms the outlet so as to preventfluid flow from the drug reservoir via the outlet and a second conditionin which the valve is at least partially disengaged from the outlet soas to allow fluid flow from the drug reservoir via the outlet.

In another aspect, an on-body injector includes a housing, with anadhesive pad associated with a lower surface of the housing andconfigured to be removably attached to a human body surface. A drugreservoir is positioned within the housing and includes an outlet and aseal, which is at least partially positioned within the drug reservoir.A needle is fluidically connected to the outlet of the drug reservoir,while a controller is configured to control the components of theon-body injector to execute a drug delivery routine. The seal isconfigured to be deformed from a first condition to a second conditionby an increase in pressure within the drug reservoir, with the sealpreventing fluid flow from the drug reservoir via the outlet in thefirst condition and the seal being at least partially open in the secondcondition so as to allow fluid flow from the drug reservoir via theoutlet.

These and other aspects of the present subject matter are set forth inthe following detailed description of the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top perspective view of a drug delivery device according toconventional design;

FIG. 2 is a bottom perspective view of the drug delivery device of FIG.1;

FIG. 3 is a top perspective view of the interior components of the drugdelivery device of FIG. 1;

FIG. 4 is a bottom perspective view of the interior components of thedrug delivery device of FIG. 1;

FIG. 5 is a perspective view of an exemplary embodiment of a reservoirand sealing system of an on-body injector according to an aspect of thepresent disclosure;

FIGS. 6-9 are cross-sectional views of the reservoir of FIG. 5, showinga process of filling the reservoir with a drug and then delivering thedrug to a subject;

FIG. 10 is a perspective view of another exemplary embodiment of areservoir and sealing system of an on-body injector according to anaspect of the present disclosure, with a valve in a closed condition;

FIG. 11 is a perspective view of the reservoir and sealing system ofFIG. 10, with the valve in an open condition;

FIG. 12 is a perspective view of yet another exemplary embodiment of areservoir and sealing system of an on-body injector according to anaspect of the present disclosure, with a valve in a closed condition;

FIG. 13 is a perspective view of the reservoir and sealing system ofFIG. 12, with the valve in an open condition;

FIG. 14 is a perspective view of another exemplary embodiment of areservoir and sealing system of an on-body injector according to anaspect of the present disclosure, with a valve in a closed condition;

FIG. 15 is a perspective view of the reservoir and sealing system ofFIG. 14, with the valve in an open condition;

FIG. 16 is a perspective view of another exemplary embodiment of areservoir and sealing system of an on-body injector according to anaspect of the present disclosure, with a seal in a closed condition;

FIG. 17 is a perspective view of the reservoir and sealing system ofFIG. 16, with the seal in an open condition;

FIG. 18 is a perspective view of yet another exemplary embodiment of areservoir and sealing system of an on-body injector according to anaspect of the present disclosure;

FIG. 19 is a cross-sectional view of the reservoir and sealing system ofFIG. 18, with a seal in a closed condition;

FIG. 20 is a cross-sectional view of the reservoir and sealing system ofFIG. 18, with the seal in an open condition;

FIG. 21 is a perspective view of another exemplary embodiment of areservoir and sealing system of an on-body injector according to anaspect of the present disclosure;

FIG. 22 is a cross-sectional view of the reservoir and sealing system ofFIG. 21, with a seal in a closed condition; and

FIG. 23 is a cross-sectional view of the reservoir and sealing system ofFIG. 21, with the seal in an open condition.

DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

The embodiments disclosed herein are for the purpose of providing adescription of the present subject matter, and it is understood that thesubject matter may be embodied in various other forms and combinationsnot shown in detail. Therefore, specific designs and features disclosedherein are not to be interpreted as limiting the subject matter asdefined in the accompanying claims.

FIGS. 5-23 illustrate exemplary embodiments of a drug reservoir andassociated sealing system for an on-body injector embodying aspects ofthe present disclosure, whereby a drug in a reservoir is accessed bymeans other than piercing a septum. The on-body injectors 100 a-100 g ofFIGS. 5-23 are not illustrated in detail, but rather only selectedcomponents are shown and described herein. It should be understood thatthe components not shown and/or described in detail herein may beprovided according to any suitable configuration, which includes thecomponents being configured and functioning as described above withregard to the conventional device 10 of FIGS. 1-4.

In the embodiment of FIGS. 5-9, the on-body injector 100 a includes ahousing 102 that contains or encloses the functional components of theon-body injector 100 a. An adhesive pad 104 is associated with a lowersurface of the housing 102 for removably attaching the on-body injector100 a to a human body surface (e.g., to an arm or an abdomen). A releasefilm may be associated with the adhesive pad 104 and removed just priorto securing the adhesive pad 104 to the body of a patient, as describedabove with regard to the conventional device 10 of FIGS. 1-4.

A drug reservoir 106 is contained within the housing 102. The drugreservoir 106 is configured to contain a liquid drug “D”, which may beinjected therein via a port or inlet 108 (as described with regard tothe device 10 of FIGS. 1-4) or may be provided therein by any suitableapproach without departing from the scope of the present disclosure. Thedrug reservoir 106 includes a sidewall 110 formed of a generally rigidmaterial that is configured to not deform as pressure within the drugreservoir 106 changes.

First and second pistons 112 and 114 are positioned within the drugreservoir 106, with the first piston 112 spaced away from an outlet 116of the drug reservoir 106 (which is shown as being defined in thesidewall 110 of the drug reservoir 106) and the second piston positionedcloser to the outlet 116. In the illustrated embodiment, the pistons 112and 114 are substantially identical, though it should be understood thatthe second piston 114 may have a different configuration than the firstpiston 112. Regardless of the particular configurations of the pistons112 and 114, they may be formed of different materials without departingfrom the scope of the present disclosure, which includes the pistons 112and 114 being at least partially formed of an elastomeric material(e.g., a rubber material) or a generally rigid material (e.g., a plasticmaterial or a metallic material).

The pistons 112 and 114 define a space therebetween that is configuredto receive a drug D (as shown in FIGS. 7-9), with each piston 112, 114forming a seal with the inner surface of the sidewall 110 of the drugreservoir 106 to ensure that the drug D remains between the pistons 112and 114 while in the drug reservoir 106. In the illustrated embodiment,the pistons 112 and 114 have circular profiles in order to form a sealwith a generally cylindrical drug reservoir 106, but it should beunderstood that the pistons 112 and 114 may be differently configuredwithout departing from the scope of the present disclosure.

Each piston 112, 114 is configured to move within the interior of thedrug reservoir 106 in a direction defined by the sidewall 110 of thedrug reservoir 106. In the illustrated embodiment, only the first piston112 is provided with a drive mechanism (which is shown in FIGS. 5-9 as apiston rod 118), with movement of the second piston 114 typically beingin response to movement of the first piston 112. While FIGS. 5-9illustrate a drive mechanism configured as a piston rod 118 (which maybe moved by a muscle wire and lever assembly of the type described abovewith regard to the device 10 of FIG. 1-4 in an exemplary embodiment), itshould be understood that a differently configured drive mechanism maybe employed without departing from the scope of the present disclosure.Additionally, while FIGS. 5-9 illustrate the second piston 114 as nothaving an associated drive mechanism, it should be understood that thesecond piston 114 may include a drive mechanism (which may be similarlyconfigured to the drive mechanism of the first piston 112 or differentlyconfigured) without departing from the scope of the present disclosure.

In an exemplary embodiment, the first and second pistons 112 and 114 areinitially positioned in the orientation of FIG. 6, with the secondpiston 114 forming a seal with the sidewall 110 that prevents fluid flowfrom the drug reservoir 106 into the outlet 116. The pistons 112 and 114may be positioned as shown in FIG. 6 prior to use, in an as-manufacturedcondition.

In one embodiment, a drug D is injected into the space between thepistons 112 and 114 via the inlet 108, which causes the first piston 112to move away from the second piston 114 to accommodate the drug D as itenters the drug reservoir 106 (FIG. 7). Alternatively, a controller 120of the on-body injector 100 a (which may be configured as describedabove with regard to the device 10 of FIGS. 1-4 or differentlyconfigured) may be configured to cause the drive mechanism 118 to movethe first piston 112 away from the second piston 114 at a designatedtime. In this case, the movement of the first piston 112 from theposition shown in FIG. 6 to the position shown in FIG. 7 reduces thepressure within the space between the pistons 112 and 114, which drawsthe drug D into the space via the inlet 108.

The nature of the drug D may vary without departing from the scope ofthe present disclosure, with on-body injectors according to the presentdisclosure being suitable for use in combination with a wide variety ofliquid drugs or drug solutions. For example, in one embodiment, themethods and devices described herein are used to deliver pegfilgrastimto a subject. Other exemplary medications include (without limitation)one or more of the following: adalimumab, rituximab, risankizumab,etanercept, trastuzumab, ado-trastuzumab emtansine, trastuzumabderuxtecan, bevacizumab, infliximab, pegfilgrastim, filgrastim,tocilizumab, golimumab, interferon beta-1a, ranibizumab, denosumab,pembrolizumab, nivolumab, aflibercept, eculizumab, ocrelizumab,pertuzumab, secukinumab, omalizumab, ustekinumab, vedolizumab,daratumumab, dupilumab, atezolizumab, natalizumab, bortezomib,ipilimumab, durvalumab, emicizumab, palivizumab, guselkumab,mepolizumab, panitumumab, ramucirumab, belimumab, abatacept,certolizumab pegol, ixekizumab, romiplostim, benralizumab, evolocumab,canakinumab, obinutuzumab, cetuximab, erenumab, blinatumomab,romosozumab, mirikizumab, inotuzumab, sacituzumab govitecan, enfortumabvedotin, brentuximab vedotin.

Regardless of the nature of the drug D, once it is positioned in thespace between the pistons 112 and 114 (which may be the entire amount ofthe drug D to be conveyed to a subject or just a portion thereof), theon-body injector 100 a is ready to deliver the drug D at the designatedtime. To do so, the controller 120 causes the drive mechanism 118 of thefirst piston 112 to move the first piston 112 toward the second piston114 (FIG. 8). In the illustrated embodiment, the second piston 114 isheld in its initial position by a first stop 122 extending into theinterior of the drug reservoir 106. The configuration of the first stop122 may vary without departing from the scope of the present disclosure,provided that it is configured to engage and prevent the second piston114 from moving away from the first piston 112. In embodiments in whicha first stop 122 is provided, the controller 120 may be configured tocause the first stop 122 to disengage the second piston 114 (e.g., bymoving the first stop 122 out of the interior of the drug reservoir 106,as shown in FIG. 8) substantially simultaneously with causing the drivemechanism 118 to move the first piston 112 toward the second piston 114.

With the second piston 114 freed to move, movement of the first piston112 toward the second piston 114 will cause both pistons 112 and 114(along with the drug D positioned in the space between the pistons 112and 114) to move in the direction of the outlet 116 (left-to-right inthe orientation of FIG. 8). Eventually, the second piston 114 will moveto the extent necessary to unseal the outlet 116, which places the drugD in the space between the pistons 112 and 114 into fluid communicationwith the outlet 116. In the illustrated embodiment, a second stop 124extends into the interior of the drug reservoir 106 to engage the secondpiston 114 and prevent further movement of the second piston 114 in thedirection in which it is being moved by the first piston 112. In analternative embodiment, movement of the second piston 114 may be stoppedby the second piston 114 coming into contact with an end of the drugreservoir 106 or by any other suitable arrangement.

While movement of the second piston 114 is prevented, the first piston112 continues to advance toward the second piston 114 (FIG. 9).Continued movement of the first piston 112 toward the second piston 114forces the drug D from the drug reservoir 106 via the outlet 116. Itwill be seen that, in the illustrated embodiment, the first piston 112is positioned so as to overlay and seal the inlet 108, such that thedrug reservoir 106 may not be refilled via the inlet 108.

From the outlet 116, the drug D moves through a fluid path definedwithin the on-body injector 100 a until it is conveyed out of theon-body injector 100 a and into the body of a patient via a needlefluidically connected to the drug reservoir 106. As described above withregard to the device 10 of FIGS. 1-4, a distal end of the needle may besharpened or beveled for piercing the skin of a patient for drugdelivery. As also described above, a flexible cannula may be associatedwith the needle, with the needle piercing the skin and then beingwithdrawn, while the distal end of the flexible cannula remains withinthe skin for drug delivery to the patient.

The nature of the seal between each piston 112, 114 and the innersurface of the sidewall 110 of the drug reservoir 106 may vary withoutdeparting from the scope of the present disclosure, provided that thepistons 112 and 114 are configured to move while the seals aremaintained. In the illustrated embodiment, each piston 112, 114 issealingly secured to the inner surface of the drug reservoir 106 by arolling diaphragm 126, which may be advantageous to the extent that arolling diaphragm will provide minimal resistance to movement of thepistons 112 and 114. While the illustrated embodiment shows the pistons112 and 114 as having similarly configured seals, it should beunderstood that the seals of the pistons 112 and 114 may be differentlyconfigured without departing from the scope of the present disclosure.

FIGS. 10 and 11 illustrate another embodiment of an on-body injector 100b embodying aspects of the present disclosure. The on-body injector 100b may be similarly configured to the embodiment of FIGS. 5-9, except fora differently configured drug reservoir 150 and sealing system.

As in the embodiment of FIGS. 5-9, the drug reservoir 150 of FIGS. 10and 11 includes a sidewall 152 formed of a generally rigid material thatis configured to not deform as pressure within the drug reservoir 150changes. FIGS. 10 and 11 do not illustrate an inlet (in which case thedrug reservoir 150 is filled during manufacture of the device), but itshould be understood that the drug reservoir 150 may be provided with aninlet, such as one of the type described above with regard to theembodiment of FIGS. 5-9. The drug reservoir 150 of FIGS. 10 and 11 alsoincludes an outlet 154 but, rather than having an outlet defined in thesidewall 152 (as in the embodiment of FIGS. 5-9), the outlet 154 isinstead associated with an end of the drug reservoir 150. A singlepiston 156 is positioned within the drug reservoir 150, adjacent to anopposite end of the drug reservoir 150. As in the embodiment of FIGS.5-9, the piston 156 forms a seal with the sidewall 152 of the drugreservoir 150 and is configured to be moved through the interior of thedrug reservoir 150 by a suitable drive mechanism (e.g., a piston rod158) in a direction defined by the sidewall 152. The piston 156 may beformed of different materials without departing from the scope of thepresent disclosure, which includes the piston 156 being at leastpartially formed of an elastomeric material (e.g., a rubber material) ora generally rigid material (e.g., a plastic material or a metallicmaterial).

The drug reservoir 150 of FIGS. 10 and 11 includes a cover 160 and avalve 162. The cover 160 is associated with the end of the drugreservoir 150 having the outlet 154, while at least a portion of thevalve 162 is positioned between the cover 160 and the outlet 154. Thecover 160 may be formed of any suitable material (e.g., a generallyrigid plastic material) and is sealingly affixed to the sidewall 152 ofthe drug reservoir 150. The cover 160 is illustrated as being generallycircular or cylindrical in shape (which may be advantageous when thedrug reservoir 150 is generally cylindrical), but it should beunderstood that the cover 160 may be differently shaped withoutdeparting from the scope of the present disclosure. Regardless of theparticular configuration of the cover 160, it defines an opening orthrough-hole 164 having an end that opens into the interior of the drugreservoir 150, with an opposite end positioned adjacent to the valve162. FIGS. 10 and 11 illustrate a substantially straight or linearthrough-hole 164 that is oriented substantially parallel to (but notcoaxial with) a central axis of the drug reservoir 150, though it iscontemplated that the through-hole 164 may be differently shaped andpositioned, provided that it defines a fluid flow path between theinterior of the drug reservoir 150 and the valve 162.

As for the valve 162, it may be formed of any suitable material (e.g., agenerally rigid plastic material) and is associated to the cover 160with a fluid-tight seal to prevent a drug in the through-hole 164 fromleaking out at the interface between the cover 160 and the valve 162.The valve 162 is illustrated as being generally circular or cylindricalin shape (which may be advantageous when the drug reservoir 150 andcover 160 are generally cylindrical), but it should be understood thatthe valve 162 may be differently shaped without departing from the scopeof the present disclosure. Regardless of the particular configuration ofthe valve 162, it defines a passage or channel 166 having an end thatopens into the outlet 154 of the drug reservoir 150, with an oppositeend positioned adjacent to the cover 160. FIGS. 10 and 11 illustrate achannel 166 having an axially extending portion 168 (adjacent to theoutlet 154) connected to a radially extending portion 170 (adjacent tothe cover 160), though it is contemplated that the channel 166 may bedifferently shaped, provided that it is configured to be oriented so asto define a fluid flow path between the through-hole 164 of the cover160 and the outlet 154 (FIG. 11).

The valve 162 is configured to be moved from a first or closed condition(FIG. 10) to a second or open condition (FIG. 11), with it being withinthe scope of the present disclosure for the valve 162 to be movable inthe opposite direction, from the second or open condition to the firstor closed condition. In the closed condition, the channel 166 ismisaligned with the through-hole 164 and/or the outlet 154, whichprevents a drug in the through-hole 164 from exiting the drug reservoir150 via the outlet 154. In the open condition, the ends of the channel166 are aligned with the through-hole 164 and the outlet 154, whichallows a drug to flow from the interior of the drug reservoir 150,through the through-hole 164 of the cover 160, through the channel 166of the valve 162, and out of the drug reservoir 150 via the outlet 154.In the illustrated embodiment, the valve 162 is configured to be rotatedabout a central axis (which coincides with the central axis of the drugreservoir 150 and a central axis of the outlet 154) from the closedcondition to the open condition. In other embodiments, the valve 162 maybe configured to move from the closed condition to the open condition insome other manner (e.g., by a sliding or translation motion).

More particularly, in the illustrated embodiment, the sealing system isprovided with a drive assembly 172 configured to rotate the valve 162from the closed condition to the open condition. The drive assembly 172shown in FIGS. 10 and 11 includes a torsion spring 174, a latch 176, anda release mechanism 178. The torsion spring 174 is configured to biasthe valve 162 toward the open condition, while the latch 176 isconfigured to prevent the torsion spring 174 from rotating the valve 162to the open condition. The release mechanism 178 is configured toactuate or release the latch 176, which allows the torsion spring 174 torotate the valve 162 into the open condition.

A free end 180 of the illustrated torsion spring 174 is secured to thevalve 162, while the coiled body of the torsion spring 174 is wrappedaround or encircles the outlet 154. The illustrated latch 176 isconfigured to selectively engage and disengage from the valve 162. Theillustrated valve 162 includes a recess 182 (FIG. 11) in which at leasta portion of the latch 176 is seated (FIG. 10) to prevent the valve 162from being rotated to the open condition by the torsion spring 174. Therelease mechanism 178 (which is illustrated as a filament) manipulatesthe latch 176 to move at least a portion of the latch 176, which causesthe latch 176 to move out of the recess 182 and disengage from the valve162. The filament 178 may be variously configured, provided that it isconfigured to actuate the latch 176 at the designated time. In oneexemplary embodiment, the filament 178 may be associated to the drivemechanism 158, with actuation of the drive mechanism 158 to move thepiston 156 also moving or actuating the filament 178, causing the latch176 to disengage the valve 162. In another exemplary embodiment, thefilament 178 is configured as a muscle wire, formed of a shape memoryalloy that contracts when heated. Heat may be applied by any suitablesource, with heat being applied by an electrical current flowing throughthe filament 178 in an exemplary embodiment. When the filament 178contracts, it pulls on the latch 176, causing the latch 176 to disengagethe valve 162, followed by the valve 162 being rotated to its opencondition by the torsion spring 174.

Thus, during a drug delivery routine, the controller 120 of the on-bodyinjector 100 b will actuate the filament 178 at the designated time,such as by causing an electrical current to be applied to the filament178. The filament 178 contracts, which disengages the latch 176 from thevalve 162. The torsion spring 174 rotates the valve 162 from the closedcondition (FIG. 10) to the open condition (FIG. 11), which places thethrough-hole 164 of the cover 160 in fluid communication with the outlet154. The controller 120 then causes the piston 156 to be moved towardthe outlet 154 of the drug reservoir 150. Continued movement of thepiston 156 toward the outlet 154 forces the drug through thethrough-hole 164 of the cover 160, through the channel 166 of the valve162, and then out of the drug reservoir 150 via the outlet 154. From theoutlet 154, the drug moves through a fluid path defined within theon-body injector 100 b until it is conveyed out of the on-body injector100 b and into the body of a patient via a needle fluidically connectedto the drug reservoir 150.

FIGS. 12 and 13 illustrate another embodiment of an on-body injector 100c embodying aspects of the present disclosure. The on-body injector 100c may be similarly configured to the embodiment of FIGS. 10 and 11, witha drug reservoir 200 having an outlet 202 at one end, with a piston 204positioned within the drug reservoir 200 adjacent to an opposite end ofthe drug reservoir 200. However, in the embodiment of FIGS. 12 and 13the drug reservoir 200 does not include a cover or a valve, but ratherthe outlet 202 opens directly into the interior of the drug reservoir200.

In place of the cover and valve of FIGS. 10 and 11, the on-body injector100 c is instead provided with an outlet 202 at least partially formedof a deformable material (e.g., an elastomeric material, such aspolyvinyl chloride). Due to the outlet 202 being deformable, it may bemoved from a closed condition (FIG. 12) in which it is deformed (e.g.,pinched shut) to prevent fluid flow through the outlet 202 to an opencondition (FIG. 13) in which it is in its initial, non-deformed state,defining an open lumen allowing fluid flow therethrough. In addition tobeing capable of moving from the closed condition to the open condition,the outlet 202 may also be configured to be moved from the opencondition to the closed condition.

A valve 206 is associated with the outlet 202 to move the outlet 202from the closed condition to the open condition. The valve 206 may bevariously configured without departing from the scope of the presentdisclosure, provided that it is suitable for moving the associatedoutlet 202 from the closed condition to the open condition. As such, itwill be understood that the configuration of the valve 206 is dependentupon the configuration of the outlet 202. In the illustrated embodiment,the outlet 202 is configured as a deformable tube, which may be closedby pressing a portion of the wall of the tube against an opposingportion of the wall (i.e., pinching the tube shut). The valve 206 ofFIGS. 12 and 13 is illustrated as having first and second jaws 208 and210, which are pivotal with respect to each other, with a portion of theoutlet 202 being positioned between the jaws 208 and 210. The jaws 208and 210 may be biased (e.g., by a torsion spring) to pivot toward eachother, which causes the jaws 208 and 210 to contact and deform theoutlet 202, placing it in the deformed or closed condition of FIG. 12.

One of the jaws 208 is associated to a release mechanism 212, whichselectively manipulates the associated jaw 208 to cause the jaw 208 topivot away from the other jaw 210. This causes the valve 206 to at leastpartially disengage from the outlet 202, placing the outlet 202 in itsopen condition and allowing fluid flow through the outlet 202. Therelease mechanism 212 may be variously configured, provided that it isconfigured to actuate the valve 206 at the designated time. In theillustrated embodiment, the release mechanism 212 is configured as inthe embodiment of FIGS. 10 and 11, which is as a filament or musclewire, formed of a shape memory alloy that contracts when heated. Asdescribed above, heat may be applied by any suitable source, with heatbeing applied by an electrical current flowing through the filament 212in an exemplary embodiment. When the filament 212 contracts, it pulls onthe jaw 208, causing the jaw 208 to at least partially disengage fromthe outlet 202, which moves the outlet 202 to its open condition (FIG.13).

Thus, during an exemplary drug delivery routine, the controller 120 ofthe on-body injector 100 c will cause an electrical current to beapplied to the filament 212 at the designated time. The filament 212contracts, which at least partially disengages the valve 206 from theoutlet 202, moving the outlet 202 from the closed condition (FIG. 12) tothe open condition (FIG. 13). The controller 120 then causes the piston204 to be moved toward the outlet 202 of the drug reservoir 200, withcontinued movement of the piston 204 toward the outlet 202 forcing thedrug D out of the drug reservoir 200 via the outlet 202. From the outlet202, the drug D moves through a fluid path defined within the on-bodyinjector 100 c until it is conveyed out of the on-body injector 100 cand into the body of a patient via a needle fluidically connected to thedrug reservoir 200.

It should be understood that the configuration of the drug reservoir 200shown in FIGS. 12 and 13 is merely exemplary and that the drug reservoirmay be differently configured without departing from the scope of thepresent disclosure. For example, FIGS. 14 and 15 illustrate an on-bodyinjector 100 d that is a variation of the on-body injector 100 c ofFIGS. 12 and 13. As described above, the drug reservoir 200 of FIGS. 12and 13 is formed of a generally rigid material, with a piston 204configured to be moved through the interior of the drug reservoir 200 toconvey a drug out of the drug reservoir 200 via the outlet 202. Incontrast, FIGS. 14 and 15 illustrate a drug reservoir 220 formed of agenerally flexible or deformable material (e.g., an elastomericmaterial, such as polyvinyl chloride).

In the embodiment of FIGS. 14 and 15, force is applied to the drugreservoir 220 to compress or deform it, which causes a drug to beconveyed out of the drug reservoir 220 via the outlet 202. The force maybe applied to the drug reservoir 220 before or after the valve 206 isopened. For example, the interior of the housing 102 may be pressurized,which causes a force to be applied to the drug reservoir 220 before theoutlet 202 is opened. When the outlet 202 is opened, the drug reservoir220 will be compressed and the drug D will be automatically conveyed outof the drug reservoir 220 via the outlet 202. In another example, thedrug reservoir 220 may be deformed by physical contact, such as byplacing at least a portion of the drug reservoir 220 between twosurfaces (e.g., two flat plates) that may be moved relative to eachother. The two surfaces may initially be spaced sufficiently far apartso as to not apply force to the drug reservoir 220 before the outlet 202is opened. Once the outlet 202 has been opened, one or both of thesurfaces may be moved toward the other surface, which applies acompressive force to the drug reservoir 220 and conveys the drug D fromthe drug reservoir 220 via the outlet 202.

FIGS. 16 and 17 illustrate another on-body injector 100 e embodyingaspects of the present disclosure. The on-body injector 100 e may besimilarly configured to the embodiment of FIGS. 10 and 11, with a drugreservoir 250 having an outlet 252 at one end, with a piston 254positioned within the drug reservoir 250 adjacent to an opposite end ofthe drug reservoir 250. However, in the embodiment of FIGS. 16 and 17the drug reservoir 250 does not include a cover or a valve positionedbetween the interior of the drug reservoir 250 and the outlet 252, butrather a deformable seal 256 is positioned therebetween. Due to the seal256 being deformable, it may be moved from a first or closed condition(FIG. 16) in which it forms a complete barrier between the interior ofthe drug reservoir 250 and the outlet 252 to prevent fluid flow out ofthe drug reservoir 250 via the outlet 252 to a second or open condition(FIG. 17) in which the seal 256 is at least partially open to allowfluid from the interior of the drug reservoir 250 to the outlet 252. Inone embodiment, the seal 256 is not capable of returning to the closedcondition from the open condition after it has been opened, which may bethe case if the seal 256 is configured to deform by breaking orrupturing, as shown in FIG. 17. When the seal is so configured (i.e., asa “burstable” seal), it may be advantageous for it to be used incombination with an on-body injector in which a drug is to becontinuously (rather than intermittently) conveyed from the drugreservoir during a drug delivery routine.

The configuration of the seal 256 and the manner in which it deforms mayvary without departing from the scope of the present disclosure. In oneembodiment, the seal 256 is at least partially formed of a material(e.g., thin metal film or foil) that is configured to be deformed by anincrease in pressure within the drug reservoir 250. Pressure may beapplied to the seal 256 by any of a variety of possible approaches, butin one embodiment, the pressure applied to deform the seal 250 ariseswhen the piston 254 is moved toward the seal 256, which increases thepressure within the drug reservoir 250. The seal 256 may be processed orotherwise configured to have at least one weakened section 258 (FIG. 16)that will break or fracture at a lower pressure than other portions ofthe seal 256. This may be advantageous to reduce the pressure requiredto move the seal 256 from its closed condition to its open condition,along with providing more control over the manner in which the seal 256breaks or fractures. If provided, the weakened section 258 may bevariously configured without departing from the scope of the presentdisclosure. For example, the weakened section 258 may be configured as ascored or perforated or creased section of the seal 256 or as a sectionhaving a thickness that is less than the thickness of other portions ofthe seal 256.

Thus, during a drug delivery routine, the controller 120 of the on-bodyinjector 100 e will cause the piston 254 to be moved toward the seal 256at the designated time. The pressure within the drug reservoir 250increases, which deforms the seal 256 from its closed condition (FIG.16) to its open condition (FIG. 17), placing the interior of the drugreservoir 250 into fluid communication with the outlet 252. Continuedmovement of the piston 254 toward the outlet 252 forces the drug D outof the drug reservoir 250 via the outlet 252. From the outlet 252, thedrug D moves through a fluid path defined within the on-body injector100 e until it is conveyed out of the on-body injector 100 e and intothe body of a patient via a needle fluidically connected to the drugreservoir 250.

It should be understood that the configuration of the seal shown inFIGS. 16 and 17 is merely exemplary and that the seal may be differentlyconfigured without departing from the scope of the present disclosure.For example, FIGS. 18-20 illustrate an on-body injector 100 f that is avariation of the on-body injector 100 e of FIGS. 16 and 17. As describedabove, the seal 256 of FIGS. 16 and 17 may be formed of a material thatis configured to deform and break or fracture on its own when pressurewithin the drug reservoir 250 increases to a sufficient level. Incontrast, FIGS. 18-20 illustrate a drug reservoir 270 having a seal 272that is configured to deform without breaking or fracturing on its ownwhen pressure within the drug reservoir 270 is increased.

Rather than the seal 272 of FIGS. 18-20 being configured to deform andbreak on its own, a piercing element 274 is associated with orincorporated into the drug reservoir 270. The piercing element 274includes an end 276 (which may be sharpened) that is configured topierce, rupture, or otherwise open the seal 272 when the seal 272 isbrought into contact with the end 276 with sufficient force. The seal272 is initially spaced away from the end 276 of the piercing element274 in its first or closed condition (FIG. 19). When the seal 272 isdeformed to its second or open condition (FIG. 20) by an increase inpressure within the drug reservoir 270, it comes into contact with theend 276 of the piercing element 274, which pierces or ruptures orotherwise opens the seal 272, opening fluid flow through the seal 272.In the illustrated embodiment, the piercing element 274 is configured asa needle or cannula defining a lumen fluidically connected to the outlet252, such that causing the piercing element 274 to pierce through theseal 272 allows a drug D in the interior of the drug reservoir 270 toflow into and through the lumen of the piercing element 274, then intothe outlet 252.

FIGS. 21-23 illustrate another on-body injector 100 g that may beunderstood as a variation of the on-body injectors 100 e and 100 f ofFIGS. 16-20. In the embodiment of FIGS. 21-23, the drug reservoir 290has a seal 292 is configured to deform from a first or closed condition(FIGS. 21 and 22) to a second or open condition (FIG. 23) on its own,upon a sufficient increase in pressure within the drug reservoir 290.While this is similar to the seal 256 of FIGS. 16 and 17, the seal 292of FIGS. 21-23 is different because it is configured to be movablebetween the closed and open conditions (i.e., it is reversiblydeformable), rather than irreversibly moving from the closed conditionto the open condition.

More particularly, the seal 292 of FIGS. 21-23 may be at least partiallyformed of an elastomeric material (e.g., a rubber material). The seal292 is initially formed in its closed condition (FIGS. 21 and 22) inwhich it provides a complete barrier between the interior of the drugreservoir 290 and the outlet 252. When pressure within the drugreservoir 290 is increased to a sufficient level (e.g., by movement ofthe piston 254 toward the seal 292), a portion or end 294 of the seal292 deforms to define an opening or fluid path through the seal 292(FIG. 23), allowing a drug D in the interior of the drug reservoir 290to flow through the opening and into the outlet 252. When pressurewithin the drug reservoir 290 decreases to a sufficient level, thedeformed portion or end 294 of the seal 292 will return to its initial,closed condition, again preventing flow through the seal 292. The seal292 of FIGS. 21-23 may, thus, be understood as and configured as a checkvalve or duck-bill valve or poppet valve or the like. When the seal isso configured (i.e., elastically or reversibly deformable), it issuitable for use in combination with an on-body injector in which a drugis to be intermittently or periodically conveyed from the drug reservoirover the course of a drug delivery routine, with the seal moving betweenclosed and open conditions multiple times.

It will be understood that the embodiments and examples described aboveare illustrative of some of the applications of the principles of thepresent subject matter. Numerous modifications may be made by thoseskilled in the art without departing from the spirit and scope of theclaimed subject matter, including those combinations of features thatare individually disclosed or claimed herein. For these reasons, thescope hereof is not limited to the above description but is as set forthin the following claims, and it is understood that claims may bedirected to the features hereof, including as combinations of featuresthat are individually disclosed or claimed herein.

The invention claimed is:
 1. An on-body injector comprising: a housing;an adhesive pad associated with a lower surface of the housing andconfigured to be removably attached to a human body surface; a drugreservoir positioned within the housing and including an elongated andgenerally tubular outlet having an end fixedly secured with respect tothe drug reservoir, and a seal at least partially positioned within thedrug reservoir and secured between the outlet and at least a portion ofthe drug reservoir; a needle fluidically connected to the outlet of thedrug reservoir; and a controller configured to control the components ofthe on-body injector to execute a drug delivery routine, wherein theseal is configured to be deformed from a first condition to a secondcondition by an increase in pressure within the drug reservoir, the sealprevents fluid flow from the drug reservoir via the outlet in the firstcondition, and the seal is at least partially open in the secondcondition so as to allow fluid flow from the drug reservoir via theoutlet.
 2. The on-body injector of claim 1, wherein the seal isconfigured as a film.
 3. The on-body injector of claim 2, wherein theseal includes at least one weakened section configured to be broken uponan increase in pressure within the drug reservoir, and said at least oneweakened section of the seal is unbroken in the first condition andbroken in the second condition.
 4. The on-body injector of claim 3,wherein the weakened section is configured as a scored section of theseal.
 5. The on-body injector of claim 3, wherein the weakened sectionis configured as a perforated section of the seal.
 6. The on-bodyinjector of claim 3, wherein the weakened section is configured as acreased section of the seal.
 7. The on-body injector of claim 3, whereinthe weakened section has a thickness that is less than a thickness ofother sections of the seal.
 8. The on-body injector of claim 2, furthercomprising a piercing element at least partially positioned within thedrug reservoir, wherein the seal is spaced away from the piercingelement in the first condition, and the piercing element engages theseal in the second condition to pierce and at least partially open theseal.
 9. The on-body injector of claim 8, wherein the piercing elementdefines a lumen fluidically connected to the outlet of the drugreservoir, and the lumen is configured to direct fluid flow from aninterior of the drug reservoir to the outlet when the seal is in thesecond condition.
 10. The on-body injector of claim 1, wherein the sealis at least partially formed of an elastomeric material.
 11. The on-bodyinjector of claim 10, wherein the seal is configured as a check valvehaving an end configured to be closed in the first condition and open inthe second condition.
 12. The on-body injector of claim 1, furthercomprising a piston at least partially positioned within the drugreservoir, wherein the piston is configured to be moved toward the sealto increase the pressure in the drug reservoir.
 13. The on-body injectorof claim 1, wherein the controller is configured to execute a drugdelivery routine for a drug comprising pegfilgrastim.
 14. The on-bodyinjector of claim 1, wherein the seal is configured to not be capable ofreturning to the first condition from the second condition.
 15. Theon-body injector of claim 1, wherein the seal is configured to becapable of returning to the first condition from the second condition.16. The on-body injector of claim 1, wherein the controller isconfigured to control the components of the on-body injector tocontinuously convey a drug from the drug reservoir during the drugdelivery routine.
 17. The on-body injector of claim 1, wherein thecontroller is configured to control the components of the on-bodyinjector to intermittently convey a drug from the drug reservoir duringthe drug delivery routine.
 18. The on-body injector of claim 1, whereinthe seal is at least partially formed of a metallic material.
 19. Theon-body injector of claim 1, wherein the seal is configured as aduckbill valve having an end configured to be closed in the firstcondition and open in the second condition.
 20. The on-body injector ofclaim 1, wherein the seal is configured as a poppet valve having an endconfigured to be closed in the first condition and open in the secondcondition.
 21. An on-body injector comprising: a housing; an adhesivepad associated with a lower surface of the housing and configured to beremovably attached to a human body surface; a drug reservoir positionedwithin the housing and including an elongated and generally tubularoutlet having an end configured to remain stationary with respect to thedrug reservoir, and a seal at least partially positioned within the drugreservoir and secured between the outlet and at least a portion of thedrug reservoir; a needle fluidically connected to the outlet of the drugreservoir; and a controller configured to control the components of theon-body injector to execute a drug delivery routine, wherein the seal isconfigured to be deformed from a first condition to a second conditionby an increase in pressure within the drug reservoir, the seal preventsfluid flow from the drug reservoir via the outlet in the firstcondition, and the seal is at least partially open in the secondcondition so as to allow fluid flow from the drug reservoir via theoutlet.
 22. An on-body injector comprising: a housing; an adhesive padassociated with a lower surface of the housing and configured to beremovably attached to a human body surface; a drug reservoir positionedwithin the housing and including an elongated and generally tubularoutlet having an end secured with respect to the drug reservoir, and aseal at least partially positioned within the drug reservoir and securedbetween the outlet and at least a portion of the drug reservoir; aneedle fluidically connected to the outlet of the drug reservoir; and acontroller configured to control the components of the on-body injectorto execute a drug delivery routine, wherein the seal is configured to bedeformed from a first condition to a second condition by an increase inpressure within the drug reservoir, the seal prevents fluid flow fromthe drug reservoir via the outlet in the first condition, and the sealis at least partially open in the second condition so as to allow fluidflow from the drug reservoir via the outlet.